Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients

• Status: Completed
• Trial end date: 2018-10-12
• Target enrollment: 0
• Participant gender: All

Summary

Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate the activity and safety of PM01183 versus PLD or topotecan as control arm in patients with platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaMar
• Treatments: Doxorubicin; Liposomal doxorubicin; Topotecan

Criteria

Inclusion Criteria:

• Age >/= 18 years

• Confirmed diagnosis of unresectable epithelial ovarian, fallopian tube or primary peritoneal cancer.

• Platinum-resistant disease (PFI: 1-6 months after last platinum-containing chemotherapy).

• Evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria

• No more than three prior systemic chemotherapy regimens

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) (ECOG PS) ≤ 2

• Adequate hematological, renal, metabolic and hepatic function

Exclusion Criteria:

• Concomitant diseases/conditions: cardiac disease, immunodeficiency, chronic active hepatitis or cirrhosis, uncontrolled infection, bowel obstruction, any other major illness

• Prior treatment with PM01183, trabectedin, or with both PLD and topotecan.

• Requirement of permanent or frequent (i.e., once per week) external drainages within two weeks prior to randomization